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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white crystalline powder | Conform |
Related Substances | Artemisitene ≤0.15% | 0.07% |
9-epimer of artemisinin ≤0.3% | ND | |
Any individual impurity ≤0.15% | 0.10% | |
Total impurities ≤1.0% | 0.75% | |
Loss on drying | ≤0.5% | 0.25% |
Residue on ignition | ≤0.1% | 0.06% |
Lead | ≤2 ppm | Conform |
Arsenic | ≤1 ppm | Conform |
Mercury | ≤0.1 ppm | Conform |
Cadmium | ≤0.1ppm | Conform |
Aerobic bacteria count | ≤1000 cfu/g | Conform |
Yeast& Mold | ≤100 cfu/g | Conform |
Escherichia coli | Negative | Conform |
Pseudomonas aeruginosa | Negative | Conform |
Staphylococcus aureus | Negative | Conform |
Assay(HPLC) | 98.0-102.0% | 99.35% |
Conclusion | Conforms to Factory Standard |
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